Materials and methods for improved bone tendon bone transplantation

ABSTRACT

Disclosed herein is an improved Bone Tendon Bone graft for use in orthopedic surgical procedures. Specifically exemplified herein is a Bone Tendon Bone graft comprising one or more bone blocks having a groove cut into the surface thereof, wherein said groove is sufficient to accommodate a fixation screw. Also disclosed is a method of harvesting grafts that has improved efficiency and increases the quantity of extracted tissue and minimizes time required by surgeon for implantation.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 14/669,782, which was filed on Mar. 26, 2015, which is acontinuation of U.S. patent application Ser. No. 13/431,459, which wasfiled on Mar. 27, 2012, which is a continuation of U.S. patentapplication Ser. No. 10/846,399 (now U.S. Pat. No. 8,167,943), which wasfiled May 14, 2004, which is a continuation of U.S. patent applicationSer. No. 09/528,034 (now U.S. Pat. No. 6,805,713), which was filed Mar.17, 2000, which is a continuation-in-part of U.S. patent applicationSer. No. 09/481,319 (now U.S. Pat. No. 6,497,726), which was filed Jan.11, 2000. The entire text of the aforementioned applications isincorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

Orthopedic medicine is increasingly becoming aware of the vast potentialand advantages of using bone/tendon/bone grafts to repair common jointinjuries, such as Anterior Cruciate Ligament (ACL) or Posterior CruciateLigament (PCL) tears. One technique that is currently used for repairingthese types of injuries involves surgically reconnecting the tornportions of a damaged ligament. However, this technique is often notpossible, especially when the damage to the ligament is extensive. Toaddress situations where the damage to the joint ligaments is severe,another technique commonly performed involves redirecting tendons toprovide increased support to a damaged knee. These conventionaltechniques are not without their shortcomings; in most cases, therepaired joint lacks flexibility and stability.

The recent utilization of bone/tendon grafts has dramatically improvedthe results of joint repair in cases of severe trauma. Even in cases ofextensive damage to the joint ligaments, orthopedic surgeons have beenable to achieve 100 percent range of motion and stability using donorbone/tendon grafts.

Despite these realized advantages, there have been some difficultiesencountered with utilizing bone/tendon grafts. For example, surgicalprocedures involving transplantation and fixation of these grafts can betedious and lengthy. Currently, bone/tendon/bone grafts must bespecifically shaped for the recipient during surgery, which can requirethirty minutes to over an hour of time. Further, surgeons must establisha means of attaching the graft, which also takes up valuable surgerytime.

Another difficulty associated with using bone/tendon grafts is thatthere is a limited supply and limited size range available. This canresult in a patient having to choose an inferior procedure simply basedon the lack of availability of tissue. Accordingly, there is a need inthe art for a system that addresses this and the foregoing concerns.

SUMMARY OF THE INVENTION

The subject invention concerns a novel bone tendon bone graft (BTB) thatfacilitates an easier and more efficient surgery for reconstructingligaments in a joint. One aspect of the subject invention pertains to aBTB that comprises a tendon and two bone blocks positioned at oppositeends of the tendon, wherein the bone blocks are pre-shaped for uniformand consistent alignment into a recipient bone.

In a specific aspect, the subject invention pertains to a bone tendonbone graft useful in orthopedic surgery comprising one or more boneblocks, and a tendon attached to said one or more bone blocks; whereinsaid one or more bone blocks is cut to provide a groove sufficient toaccommodate a fixation screw. Alternatively, the subject inventionpertains to a bone tendon bone graft useful in orthopedic surgerycomprising one or more bone blocks and a tendon attached to said one ormore bone blocks, wherein said one or more bone blocks is pre-shapedinto a dowel.

A further aspect of the subject invention pertains to a method ofobtaining a plurality of bone tendon bone grafts comprising excising afirst bone plug having attached thereto a tendon or ligament; andexcising a second bone plug having attached thereto a tendon orligament; wherein said first bone plug and said second bone plug arederived from contiguous bone stock and overlap such that excision ofsaid first bone plug or said second bone plug forms a groove in the boneplug that is excised subsequent to the other.

In yet another aspect, the subject invention pertains to a method ofconducting orthopedic surgery on a human or an animal comprisingobtaining a bone tendon bone graft, said graft comprising a tendon orligament having two ends, and one or more bone blocks attached to saidtendon or ligament, wherein at least one of said one or more bone blockshas a groove suitable for accommodating a fixation screw.

An alternative aspect of the invention pertains to an implant comprisinga bone block and a tendon, wherein the bone block comprises a groove foraccommodating a fixation screw.

These and other advantageous aspects of the subject invention aredescribed in further detail below.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an embodiment of a BTB having a groove with a threadprofile disposed thereon.

FIG. 2A-C shows a side view of three different embodiments of BTBs inaccordance with the subject invention.

FIG. 3 depicts a frontal view of a donor area for harvesting BTBs inaccordance with the teachings herein.

FIG. 4 is a depiction of another embodiment of the inventionillustrating a reconstruction of an injured area through implantation ofa BTB in accordance with the teachings herein.

FIG. 5 shows a side view of a BTB core cutter of the subject inventiondesigned for harvesting BTB grafts.

FIG. 6A shows a close up view of a teeth configuration that is lessdesired for use with the subject invention.

FIG. 6B shows a close up view of a preferred embodiment of the teeth ofthe embodiment shown in FIG. 5.

FIG. 7 is a blown up view of the circled region as shown in FIG. 5.

FIG. 8 is three dimensional side view of a further embodiment of thesubject BTB that comprises one block that is tapered on both ends.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIG. 1, there is shown an embodiment directed to a BTB 100comprising a first bone block 110 and a second bone block 120interconnected by a tendon 130, wherein each bone block has beenpre-shaped into dowels. The term “tendon” as used herein is intended inits broad sense and refers to fibrous connective tissue for use ingrafts, such as, but not limited to, tendons, ligaments anddemineralized bone. The terms “BTB” or “bone tendon bone graft” as usedherein refer to a graft implant that comprises one or more tendonportions and one or more bone portions. The BTB is preferably isolatedfrom the knee of a donor. However, in view of the teachings herein,those skilled in the art will readily appreciate that other areas of thebody are suitable, albeit less preferred, for harvesting BTBs accordingto the subject invention, such as, but not limited to, the Achillestendon/calcaneus region or shoulder region. In addition to BTBs having atendon portion derived from naturally occurring tendon or ligamentharvested from a donor, other examples of suitable implants would bereadily appreciated by those skilled in the art, such as, but notlimited to, segmentally demineralized bone (International Pub. No.WO/99/21515). In a more preferred embodiment, one of the bone blocks isderived from the patella while the other is derived from the end of thetibia, and the tendon is derived from the patellar tendon.

To facilitate placement of a fixation screw, the dowels are preferablymachined down the length of the bone block to form radius cuts 115, 125.The radius cuts 115, 125 aid in the attachment of the graft to recipientbone because they provide a groove to position a fixation screw, whichresults in increased surface area at the contact between the bone blockand the screw. The radius cuts 115, 125 provide the additional advantageof increasing the pull out loads of the bone block, as well as fillingof “dead” space in the tunnel.

Fixation methods known in the art can be used in accord with theprinciples of the subject invention, which include, but are not limitedto, staples, buttons, screw and washer, interference screws, andself-taping screws. In a preferred embodiment, fixation is accomplishedby interference screws and/or self-taping screws. In an even morepreferred embodiment, the radius cuts 115, 125 contain a thread profile135 that matches the thread profile of the fixation screw, therebyfurther increasing the stability of fixation.

Referring now to FIG. 2, three different embodiments of the subject BTBsare shown. FIG. 2A shows an embodiment that comprises a basicconfiguration of the subject BTBs. Bone blocks 210 and 220 are in apre-shaped dowel form with no groove thereon, and are connected bytendon 100. FIG. 2B shows another version of the BTB, wherein the boneblocks are pre-shaped into dowels with tapered ends. Bone block 212 is adowel that has a proximal tapered region 216 in relation to tendon 200,and bone block 214 is preshaped into a dowel that has a distal taperedregion 218 in relation to tendon 200. FIG. 2C illustrates a preferredversion of the invention, which has a bone block 230 with a proximaltapered region 239 and a groove 238 positioned on the bone block 230.This version also comprises a second bone block 234 with a distaltapered region and a groove 236 positioned on bone block 234 as well.The embodiments shown in FIGS. 2B-C are tapered such that implantationinto a pre-formed tunnel in recipient to bone is preferred to occur inthe direction of the arrow (see also FIG. 4).

Referring to FIG. 3, an illustration of a donor area 300 is depicted,wherein three separate grafts 335, 345, and 355 are harvested. As shown,the three different grafts individually have at least one bone block330, 340, and 350. While the sequence of harvesting the grafts is notcritical, preferably, graft 335 is excised first, followed by excisionof the outside grafts 345, 355. Excising graft 335 first results in theautomatic cut in the other donor areas, thereby producing a groove inthe bone blocks 340, 350 of the other grafts upon excision. In apreferred embodiment, the donor area is located at the top of the Tibiaat the insertion of the patellar tendon 320. In an even more preferredembodiment, the donor area extends the length of the patellar tendon tothe patella, wherein bone blocks are excised from the patella.

The bone blocks can be extracted with the use of conventional tools andprotocols routinely practiced in the art, such as core cutter and holesaws. In a preferred embodiment, the bone blocks can be extractedthrough the use of a BTB bone cutter according to the teachings furtherdescribed below.

The extracted bone blocks 330, 340, and 350 are generally shaped like aplug or dowel and are preferably further shaped by machining throughconventional methods known in the art. In a specific embodiment thedowel is machined into dimensions suitable for various surgicalprocedures. The machining is preferably conducted on a graduated die, agrinding wheel, a lathe, or machining tools may be specifically designedand adapted for this purpose in view of the teachings herein. Preferreddimensions for the dowels include 8 mm, 9 mm, 10 mm, 11 mm, and 12 mm indiameter. Reproducibility of the product dimensions is an importantfeature for the successful use of such grafts in the clinical setting.

In a specific embodiment, the subject invention is directed to a methodof repairing an injured cruciate ligament in the knee involving theimplantation of a BTB. FIG. 4 illustrates this procedure, and shows afemur 400 and tibia 410 having tunnels formed therein, 466 and 462,respectively, for receiving BTB 430, which comprises two bone blocks 432and 434 connected by tendon 433. To aid in guiding the BTB 430 throughtunnel 462, sutures 460 are optionally engaged to bone block 432, whichallow a surgeon to pull the BTB 430 through tunnel 462 where the sutures460 can then be removed. Once the BTB 430 is properly situated intunnels 462 and 466, the BTB 430 is secured in the recipient bone byinterference screws 440. The interference screws 440 are preferably selftaping and are engaged by rotation in the space between grooves 438 and436 and the inner walls of tunnels 466 and 462, respectively. In an evenmore preferred embodiment, the BTB can be pre-marked with alignmentmarkings. Such markings can be positioned on the BTB to aid the surgeonin visualizing the depth of the BTB in the tunnels formed for receivingthe BTB, as well as visualizing bone ligament junctions and rotation ofthe BTB.

Referring now to FIGS. 5-7, another embodiment of the subject inventionis shown that is directed to a BTB harvesting device, such as corecutter 500 that comprises a shaft 502 having a first end 503 and asecond end 505. The first end 503 of the shaft 502 preferably has acavity 501 longitudinally disposed thereon, which is designed forengaging a drill, such as by insertion of a Jacob's chuck attached to apower drill (e.g., Dupuy). The second end 505 of the shaft 502 can beattached to a first end 512 of a hollow cylinder 504. The second end 514of the cylinder 504 preferably has teeth 510 disposed thereon. In apreferred embodiment the cylinder has at least one slot 506 disposed onits surface to aid in the removal of the cut graft tissue from the corecutter 500. The slot 506 also provides a means to wash the graft duringthe extraction procedure to thereby decrease the chance of frictionalburning of the graft. In a preferred embodiment, the shaft 502 isapproximately 90 mm in length, the cylinder 504 is approximately 50 mmin length, and the slot 506 is approximately 30 mm in length. In an evenmore preferred embodiment, the first end of the hollow cylinder 512 hasa chamfered portion 522 which angles down to the shaft 502.

A blown up view of the core cutter teeth 510 is illustrated in FIG. 6.It is preferred that the radius of the teeth A and rake angle of theteeth B (also referred to as a bottom angle) are of appropriate valuesas to avoid failure (e.g. bending or breaking) of the teeth, as well asundesired damage to the graft. For example, FIG. 6A shows anunacceptable tooth pattern wherein the radius A and bottom angle B aretoo large, resulting in insufficient support structure for the tooth andinevitable failure. According to the subject invention, a core cutterhaving a diameter of approximately 10-11 mm preferably has approximately14 teeth, with a tooth radius A of approximately 20-30 mm (25 mm beingmore preferred) and a bottom angle B of approximately 10-20 degrees (15degrees being more preferred). For core cutters designed for smaller orlarger bone blocks, the foregoing dimensions are preferably maintained,while the number of teeth are appropriately decreased or increased. In apreferred embodiment, the number of teeth are decreased or increased bytwo for every millimeter below or above, respectively, the 10-11 mmcylinder diameter. For example, a core cutter having a 12 mm cylinderdiameter would preferably have about 16 teeth.

A blown up view of an end section (circle shown in FIG. 5) of thecylinder 504, is shown in FIG. 7, which illustrates a preferredembodiment of the cylinder 504 wherein the internal diameter (ID) isdecreased slightly by adding a relief thickness 520 to the inner surfaceof the cylinder 504. This embodiment provides an additional conveniencewhen using a size gauging device (e.g. ring) for selecting extractedbone blocks that are within desired parameters. For example, theselection of a BTB through a 10 mm sized gauging device would preferablyrequire the BTB to be a slight fraction smaller in diameter than thegauging device, otherwise any insignificant irregularity in the shape ofthe BTB might cause it to fail to pass through the gauging device. Therelief thickness 520 decreases the ID of the cylinder 504, therebyeffectuating this slight modification to the BTB.

Shown in FIG. 8 is a further embodiment 800 of the subject BTB that isespecially adapted for implantation during knee surgery, wherein theimplantation and securement of the BTB is bi-directional. BTB embodiment800 comprises one bone block portion 810 and one tendon portion 820. Apreferred area from which embodiment 800 is harvested would be the heel,thigh, or shoulder. More preferably, the area from which embodiment 800is harvested is the heel or thigh, whereby tendon portion 820 is derivedfrom an Achilles tendon or quadriceps tendon of a donor. The bone blockportion 810 comprises two ends 812 and 814 which both comprise a taperedregion 816 and 818, respectively. The presence of the two taperedregions 812 and 814 allows for the BTB embodiment 800 to be inserted andsecured bi-directionally, which means, for example, implantation ineither the tibial 462 or femoral 466 tunnels as discussed above inreference to the method diagrammed in FIG. 4. Of course, the site ofimplantation could be approached from a superior point of entry, i.e.,establishing a through-tunnel in the femur as opposed to the tibia; BTBembodiment 800 would be suitable for securement in either tunnels insuch alternative procedure as well. Further, the bone block 810 can beprovided with a groove 850 to aid in the securement of the implant. Inaddition, during implantation, it may be desirable to have a means formanipulating the implant, such as by sutures or graft insertion tools.Accordingly, BTB embodiment 800 is provided with preformed graftmanipulation holes 852 and 854 for receiving a suture and/or graftinsertion tools. By way of example of illustrating the orientation ofthe graft manipulation holes, holes 852 and 854 are shown as beingvertical or horizontal, respectively, to the axis of the bone block 810.The preformed graft manipulation holes can be made by conventionalmethods, such as by drilling. Appropriate tools for insertion intopreformed holes 852 and 854 will easily be appreciated by those skilledin the art. Preferably, the graft insertion tool(s) used comprise an endhaving a shape and size suitable for insertion into the graftmanipulation holes.

Those skilled in the art will appreciate that the graft may be anautograft, allograft, or xenograft. Xenograft implants may furtherrequire treatments to minimize the level of antigenic agents and/orpotentially pathogenic agents present in the graft. Techniques nowknown, or those which are later developed, for preparing tissue suchthat it is suitable for and not rejected by the recipient areincorporated herein. In cases where the graft is an allograft orxenograft, a donor is preferably screened for a wide variety ofcommunicable diseases and pathogens, including human immunodeficiencyvirus, cytomegalovirus hepatitis B, hepatitis C and several otherpathogens. These tests may be conducted by any of a number of meansconventional in the art, including, but not limited to, ELISA assays,PCR assays, or hemagglutination. Such testing follows the requirementsof the following associations: (a) American Association of Tissue Banks.Technical Manual for Tissue Banking, Technical Manual-MusculoskeletalTissues, pages M19-M20; (b) The Food and Drug Administration, InterimRule, Federal Register, Vol. 58, No. 238, Tuesday, December 14, Rulesand Regulations, 65517, D. Infectious Disease Testing and DonorScreening; (c) MMWR, Vol. 43, No. RR-8, Guidelines for PreventingTransmission of Human Immunodeficiency Virus Through Transplantation ofHuman Tissue and Organs, pages 4-7; (d) Florida Administrative Weekly,Vol. 10, No. 34, Aug. 21, 1992, 59A-1.001-014, 59A-1.005(12)(c), F.A.C.,(12)(a)-(h), 59A-1.005(15, F.A.C., (4) (a)-(8). In addition to a batteryof standard biochemical assays, the donor, or their next of kin can beinterviewed to ascertain whether the donor engaged in any of a number ofhigh risk behaviors such as having multiple sexual partners, sufferingfrom hemophilia, engaging in intravenous drug use etc. Once a donor hasbeen ascertained to be acceptable, the tissue for obtention of the BTBsas described above are recovered and cleaned.

The teachings of all patents and publications cited throughout thisspecification are incorporated by reference in their entirety to theextent not inconsistent with the teachings herein.

It should be understood that the examples and embodiments describedherein are for illustrative purposes only and that various modificationsor changes in light thereof will be suggested to persons skilled in theart and are to be included within the spirit and purview of thisapplication and the scope of the appended claims.

Example 1: Procedure for Harvesting of Crude BTB for Patellar TendonTibial Donor

A BTB was harvested according to the following procedure:

1. Using blunt and sharp dissection remove the three layers ofconnective tissue from the anterior portion of the tendon.

2. Using scalpel or scissors cut along the medial and lateral borders ofthe tendon. Use the scissors to bluntly dissect under the tendon toseparate it from the fat layer.

3. Cut around the Patellar block to separate it form the proximal tibiaand distal femur. Leave approximately 4 cm of quadriceps tendon attachedto the patellar if required. If no quadriceps tendon attachment isspecified then remove quadriceps from patellar completely using sharpdissection.

4. Pull tendon away from capsule and remove all excess adipose tissue tothe point of tibial insertion.

5. With a saw make a transverse cut through approximately the tibialtuberosity about 30 mm from the tendon insertion point. Make a similarcut about 5 mm proximal to the insertion point, which will remove thetibial plateau.

6. With a saw, cut and square the sides of the tibia bone block evenwith the tendon.

7. With a saw cut and square the patella block on three sides (ifquadriceps tendon is still attached square off only the medial andlateral sides).

8. Remove all extraneous soft tissue and cartilage from the patella,tibial tuberosity and tendon.

9. To hemisect the patellar tendon use a scalpel to divide the tendoninto a medial half and a lateral half. Each half should be 14 mm orgreater unless otherwise specified.

10. Using a saw, split the patella block and the tibia block in halffollowing the same medial/lateral line used to split the tendon.

11. Thoroughly lavage the bone blocks with sterile water or saline.

Example 2: Procedure for Forming Patellar Tendons with Preshaped Dowelsfor Patellar Tendon Tibial Donor

A BTB was harvested according to the following procedure:

1. Using blunt and sharp dissection remove the three layers ofconnective tissue from the anterior portion of the tendon.

2. Using a scalpel or scissors cut along the medial and lateral bordersof the tendon to separate it from the fat layer.

3. Cut around the Patellar block to separate it from the proximal tibiaand distal femur.

4. Pull tendon away from capsule and remove all excess adipose tissue tothe point of tibial insertion.

5. With a saw make a transverse cut through the tibial tuberosity about30 mm from the tendon insertion point. Make a similar cut just proximalto the insertion point removing the tibial plateau. Make another cutacross the coronal plane 20-30 mm posterior from the insertion point.

6. With a saw square the sides of the tibia bone block.

7. With a saw cut and square the patella block on the three sides.

8. Attach a vice to the tabletop. Place the tibia bone block in the viceso that it holds it along the proximal and distal sides. The distal sideof the bone block should be facing the processor with the tendon goingaway from them. Tighten the vice so that it holds the bone securely butdoes not crush it.

9. Attach a Jacob's chuck to a drill and insert the appropriate sizecutter. Tighten the chuck with the chuck key. Note: At least two plugsshould be cut from each bone block.

10. Position the cutter against the bone block so the teeth of thecutter will skim just over the top of the tendon without catching thetendon. Position the cutter so that the maximum attachment is obtainedthroughout the length of the bone plug.

11. Turn drill on and begin drilling the plug. When the cutter nears theend of the plug, slow the drill until the cutter just breaks through theproximal end of the bone block. Remove the plug from the cutter anddrill without damaging the tendon.

12. Repeat steps 10 and 11 for the second plug.

13. Using scissors or a scalpel hemisect the tendon into medial andlateral halves.

14. Remove the excess bone from the table vice and place the patellabone block into the vice so that it holds it along the medial andlateral sides of the block. The proximal side of the patella should befacing the processor with the tendon going away from them. Tighten thevice so that it holds the bone block securely but does not crush it.

15. Repeat steps 10 and 11 for both plugs.

16. When the plugs are completed, remove the excess patella bone fromthe vice and detach the vice from the table.

17. Remove the cutter from the Jacob's chuck and place a 1.5 mm drillbit into the chuck. Tighten with the chuck key.

18. Using a saw, cut each plug to approximately 30 mm in length (no lessthan 45 25 mm)

19. Using the Arthrex clamp, place the plug into it with the end of theplug flush with the end of the clamp. Position the plug in theanterior/posterior position. Using the first guide hole nearest theflush end of the plug, drill a hole through the plug with the 1.5 mmdrill bit. Turn the plug 180 degrees so that it is positioned in themedial/lateral position. Use the second guide hole from the flush end ofthe plug to drill a second hole through the plug.

20. Repeat step 19 for all bone plugs.

21. Using a sizing apparatus insert each bone plug into the appropriatesize gauge. The entire BTB should slide completely through easily. Trimif necessary.

22. Thoroughly lavage bone plugs with sterile water or saline.

We claim:
 1. A method of conducting orthopedic surgery on a recipientcomprising: before the surgery, obtaining a bone/tendon allograftcomprising (a) a first human bone block said first human bone blockpre-shaped before surgery as a first pre-shaped dowel bone block havinga dowel diameter specially adapted for fixation in a bone tunnel havinga tunnel diameter for which the dowel is adapted, and (b) a tendonattached to said first human bone block via a naturally occurringattachment; during the surgery, implanting the first human bone block insaid bone tunnel having a diameter for which the first pre-shaped dowelbone block is adapted.
 2. The method of claim 1, in which implantingcomprises affixing said first dowel to a bone of the recipient.
 3. Themethod of claim 2, in which said first human bone block is derived froma patella, femur, calcaneus region, or tibia.
 4. The method of claim 2,in which said orthopedic surgery is a repair or replacement of anAnterior Cruciate Ligament or Posterior Cruciate Ligament.
 5. The methodof claim 2, in which the first human bone block is not shaped during thesurgery.
 6. The method of claim 1, in which: the pre-shaped bone/tendonallograft is a bone/tendon/bone allograft further comprising a secondhuman bone block that has been pre-shaped as a second dowel having adowel diameter specially adapted for fixation in a bone tunnel having adiameter; the method further comprising, during the surgery, implantingthe second dowel in a bone tunnel having a diameter for which the seconddowel is specially adapted.
 7. The method of claim 6, in whichimplanting comprises affixing both of said first dowel and said seconddowel to a bone of the recipient.
 8. The method of claim 7, in whicheach of said first bone block and said second bone block of thebone/tendon/bone allograft is derived from a patella, femur, calcaneusregion, tibia or combination of two or more of these.
 9. The method ofclaim 7, in which said orthopedic surgery is a repair or replacement ofan Anterior Cruciate Ligament or Posterior Cruciate Ligament.
 10. Themethod of claim 7, in which the bone/tendon/bone allograft is not shapedduring the surgery.
 11. The method of claim 6, in which the bone blocksof the bone/tendon/bone allograft are derived from a patella and a tibiaand the tendon of the bone/tendon/bone allograft is derived from apatellar tendon.
 12. The method of claim 11, in which said orthopedicsurgery is a repair or replacement of an Anterior Cruciate Ligament orPosterior Cruciate Ligament.
 13. The method of claim 6, in which thebone/tendon/bone allograft is not shaped during the surgery.
 14. Themethod of claim 6, wherein both said first dowel comprises a diameter ofabout 8 mm to about 12 mm, and said second dowel comprises a diameter ofabout 8 mm to about 12 mm.
 15. The method of claim 6, wherein saidsecond dowel is attached to said tendon via a naturally occurringattachment.
 16. The method of claim 6, wherein said tendon forms atleast a portion of an outer surface of said second dowel.
 17. The methodof claim 1, wherein said dowel comprises a diameter of about 8 mm toabout 12 mm.
 18. The method of claim 1, wherein said tendon forms atleast a portion of an outer surface of said first pre-shaped dowel boneblock.